Ecocareers · 1 month ago
Data Integrity SME (Quality Assurance)
San Francisco, CA
Full-time
Onsite
Senior Level
5+ years expEcocareers is seeking a highly skilled Data Integrity SME with a strong Quality Assurance background and hands-on experience in analytical equipment documentation within the pharmaceutical industry. The ideal candidate will ensure data integrity compliance across analytical systems and support ongoing QA activities related to laboratory instrumentation.
Staffing & Recruiting
Responsibilities
Serve as the Subject Matter Expert (SME) for Data Integrity across analytical laboratory systems
Review, assess, and verify the data ranges, electronic records, and audit trail functionality of analytical instruments
Lead data integrity gap assessments and remediation activities for QC analytical equipment
Ensure compliance with FDA, GMP, ALCOA+, and pharmaceutical industry standards
Collaborate with QC, QA, and IT teams to ensure proper documentation, system configuration, and control of analytical lab equipment
Review and author technical documentation, including SOPs, validation reports, protocols, and equipment lifecycle documents
Support investigations, CAPAs, and change controls related to analytical systems
Provide QA oversight for analytical instrument qualification, calibration, and system updates
Train laboratory users on data integrity requirements and best practices
Qualification
Required
Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Engineering, or a related discipline
5–10+ years of experience in Quality Assurance within a GMP-regulated pharmaceutical or biotech environment
Strong hands-on background with analytical laboratory equipment (HPLC, UPLC, GC, UV, IR, Dissolution, etc.)
Proven expertise in Data Integrity principles, protocols, assessments, and remediation
Experience reviewing analytical instrument data, metadata, audit trails, and system configurations
Strong understanding of 21 CFR Part 11, Annex 11, ALCOA+ principles, and GxP documentation practices
Excellent communication and documentation skills
Ability to start within 2 weeks of offer
Experience in QC/QA oversight of computerized systems
Background in laboratory informatics systems (e.g., Empower, LabSolutions, Chromeleon, LIMS)
Prior experience working in top-tier pharmaceutical environments
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase